MHRA Strategy 2030 (14 October 2026)

Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. This five-year strategy sets out how they are seeking to modernise regulation in response to rapid advances in science, technology and global healthcare.

Content

As part of this Strategy, the MHRA articulate the six defining characteristics below that will guide how they work, how they engage externally and how they assess our impact:

Trusted

Trust is fundamental to effective regulation. In an era of mis- and dis-information and declining confidence in institutions we must be transparent, evidence-based, objective and clear to maintain trust. We will translate our scientific and regulatory expertise into accessible information for patients and clinicians, enabling them to make informed choices and reinforcing public confidence in our decisions.

Patient-centred

Patients and the public are at the heart of everything we do. Protecting public health means ensuring timely access to safe and effective medicines and medical devices and making sure these products continue to meet expected standards of safety in everyday use. Regulatory decision-making must also achieve the right balance between benefit and risk. We will continue to apply rigorous, proportionate judgement across the entire product lifecycle to protect patients and the public while ensuring they benefit from innovation. Hosting England’s Patient Safety Commissioner is a critical part of our commitment to involving patients and their advocates, and we will uphold their Patient Safety Principles across our work.

High-performing

Delivering consistently high standards of performance will be essential to delivering our mission. The gains the MHRA have delivered in recent years have helped boost the confidence of the life sciences sector and the health system in timeliness of regulatory decisions and activity, as well as ensuring supply chain security. Sustaining and improving on these gains and delivering ‘business as usual’ to a high standard will be one of our highest priorities. This matters because delays in regulatory decisions directly affect patients, particularly for those with rare, progressive or life-threatening-limiting conditions. We will accelerate approvals where evidence allows, act swiftly when new risks emerge and ensure regulatory pathways keep pace with scientific advances.

Scientifically excellent

Scientific excellence underpins all our work. The MHRA’s global reputation is built on rigorous science, expert judgement and integrity. Independent advice from external voices and experts, such as the Commission on Human Medicines, is central to our decision-making. We play a leading national and international role in assuring the quality of biological medicines and diagnostics. Assets such as the British Pharmacopoeia, the Clinical Practice Research Datalink (CPRD) and the Yellow Card scheme strengthen our use of evidence and our ability to protect patients. Together, these capabilities connect us to the UK’s wider scientific ecosystem and reinforce the UK’s standing as a trusted scientific leader.

Collaborative

The MHRA is a key part of the UK health system. Patient safety increasingly depends not only on the performance of regulated products, but also on how they are deployed, integrated and monitored within complex health and care systems. We will work closely with partners across the UK to support joined-up approaches to safety, oversight and access, ensuring our regulation works effectively for patients in all four UK nations.

Our influence also extends beyond the UK. We actively shape global regulatory practice, working with trusted partners to align where it benefits patients and diverging only where there is a clear purpose. As a global leader in biological measurement and a World Health Organization (WHO) Collaborating Centre, we play a vital role in assuring the safety and quality of medicines worldwide. Working closely with government partners, we will continue to ensure the security of the UK’s medical products supply chain in the face of global disruption and future emergencies.

Pro-innovation

Supporting UK innovation and prosperity is integral to our mission. As outlined in the Government’s Life Sciences sector plan and Industrial Strategy, life sciences are a major driver of growth, direct investment and high value jobs, as well as a source of transformative health benefits for patients. Regulation is a critical enabler. When UK regulation is fast, predictable, proportionate and scientifically robust, organisations can invest and grow, health systems can adopt with confidence, and patients access treatments more quickly. The regulatory decisions we make on licensing, approvals and safety will always be taken independently and objectively, guided by our statutory duties and our overriding priority of patient safety. By combining scientific excellence with pace, openness and collaboration, we will support innovation while ensuring that its benefits are realised for patients across the UK.